Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293579
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2006-02-15
Brief Title:
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will estimate overall response rate of pemetrexed in poor risk patients with advanced metastatic or recurrent squamous cell carcinoma of the head and neck
Detailed Description:
Rationale Patients with advanced stage head and neck cancer especially those with disease in the hypopharynx oropharynx or oral cavity and poor performance status defined through clinical testing are often not eligible for clinical trials and treated with best supportive care The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers including head and neck cancer with a response rate that is similar to other single chemotherapy drugs In addition previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation Along with pemetrexed the current study provides study participants with both folic acid and B12
Purpose The primary objective of this study is to evaluate tumor response including complete and partial remission and toxicities from pemetrexed in patients with advanced head and neck cancer Secondary objectives of this study include measurements of time to tumor progression survival and patient quality of life
Treatment Study participants will be given pemetrexed through intravenous infusions Pemetrexed will be administered once every three weeks This schedule of pemetrexed once every three weeks will be repeated up to six times Study participants will also be provided with both folic acid and B12 vitamin supplementation before during and after study treatments with pemetrexed Vitamin supplementation is considered critical and compliance must be followed closely Several tests and exams will be given throughout the study to monitor patients Treatments will be discontinued due to disease growth and unacceptable side effects
Purpose The primary objective of this study is to evaluate tumor response including complete and partial remission and toxicities from pemetrexed in patients with advanced head and neck cancer Secondary objectives of this study include measurements of time to tumor progression survival and patient quality of life
Treatment Study participants will be given pemetrexed through intravenous infusions Pemetrexed will be administered once every three weeks This schedule of pemetrexed once every three weeks will be repeated up to six times Study participants will also be provided with both folic acid and B12 vitamin supplementation before during and after study treatments with pemetrexed Vitamin supplementation is considered critical and compliance must be followed closely Several tests and exams will be given throughout the study to monitor patients Treatments will be discontinued due to disease growth and unacceptable side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None